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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
510(k) Number K250273
Device Name BinaxNOW COVID-19 Ag Card
Applicant
Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Applicant Contact Kristen Cyr
Correspondent
Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Correspondent Contact Kristen Cyr
Classification Product Code
QVF  
Date Received01/30/2025
Decision Date 06/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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